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2018_packaging_guidelines_en
2018_packaging_guidelines_en
2018_packaging_guidelines_en
NOTICE TO APPLICANTS
July 2018
This guideline is part of the Notice to Applicants Volume 2C - Medicinal Products for
Human Use - Regulatory Guidelines of
The Rules governing Medicinal Products in the European Union
Revision 14
Update from July 2013 (Directive 2001/83/EC as amended for the last time by Directive
2012/26/EU1 and Regulation (EC) No726/2004 as amended for the last time by Regulation
(EU) No 1027/20122).
Revision 14.1
Update from March 2015, which only concerns the Annex.
1
OJ L 299 of 27.10.2012, p.1.
2
OJ L 316 of 14.11.2012, p. 38
Revision 14.3
Update from July 2015, which only concerns the Annex. Update of the information regarding
AT, CZ, ES and FR.
Revision 14.4
Update from December 2016, which only concerns the Annex. Update of the information
regarding AT and BE.
Revision 14.5
Update from July 2018, which only concerns the Annex. Update of the information regarding
BE and FR.
2
Legal framework ................................................................................................... 3
Purpose ................................................................................................................... 4
Section A - Labelling ............................................................................................. 5
1. The text of the labelling.................................................................................................... 5
2. Language ........................................................................................................................... 5
3. Additional labelling information required by some Member States ........................... 6
4. Legal status .......................................................................................................................... 7
5. Marketing authorisation number ................................................................................... 7
6. Optional information under Article 62 of the Directive ............................................... 7
7. Blind and partially-sighted patients ............................................................................... 8
8. Control of the conformity of the labelling with the Directive ...................................... 8
9. Changes to the labelling ................................................................................................... 9
Section B - Package leaflet .................................................................................. 10
1. The text of the package leaflet ....................................................................................... 10
2. Language ......................................................................................................................... 10
3. Optional information under Article 62 of the Directive ............................................. 11
Local representative .............................................................................................................. 11
5. Blind and partially-sighted patients ............................................................................. 12
6. Control of the conformity of the package leaflet with the Directive.......................... 12
7. Changes to the package leaflet ...................................................................................... 12
Section C - Presentation of the medicinal product........................................... 14
1. Pack sizes ......................................................................................................................... 14
2. Pack design (logo, colour, etc. ) ..................................................................................... 14
ANNEX ................................................................................................................. 15
3
Legal framework
Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down
Community procedures for the authorisation and supervision of medicinal products for human
and veterinary use and establishing a European Medicines Agency3 (hereinafter "the
Regulation") lays down a centralised Union procedure for the authorisation of medicinal
products. This means that there is a single application, a single evaluation and a single
authorisation allowing direct access to the EU market of a medicinal product bearing a single
set of information.
The Regulation provides that an application for the authorisation of a medicinal product for
human use should specifically and completely include the particulars and documents as referred
in particular in Article 8(3)(j) of Directive 2001/83/EC which provides that:
"The application [for a marketing authorisation] shall be accompanied by the following
particulars and documents […]: […] a mock-up of the outer packaging, containing the details
provided for in Article 54, and of the immediate packaging of the medicinal product, containing
the details provided for in Article 55, together with a package leaflet in accordance with Article
59".
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on
the Community code relating to medicinal products for human use4 (hereinafter "the Directive")
contains, in Title V 'Labelling and Package Leaflet', provisions on the text of the label and
package leaflet of medicinal products placed on the EU market.
Article 60 of the Directive provides that "Member States may not prohibit or impede the
placing on the market of medicinal products within their territory on grounds connected with
labelling or the package leaflet where these comply with the requirements of this Title".
Article 57 of the Directive provides that:
"Notwithstanding Article 60, Member States may require the use of certain forms of labelling of
the medicinal product making it possible to ascertain:
— the price of the medicinal product,
— the reimbursement conditions of social security organizations,
— the legal status for supply to the patient, in accordance with Title VI,
— authenticity and identification in accordance with Article 54a(5).
For medicinal products authorised under Regulation (EC) No 726/2004, Member States shall,
when applying this Article, observe the detailed guidance referred to in Article 65 of this
Directive".
Article 65(f) of the Directive provides that:
"In consultation with the Member States and the parties concerned, the Commission shall draw
up and publish detailed guidance concerning in particular […] harmonised provisions for the
implementation of Article 57".
3
OJ L 136, 30.04.2004, p. 1
4
OJ L 311, 28.11.2001, p. 67
4
Article 62 of the Directive provides that:
"The outer packaging and the package leaflet may include symbols or pictograms designed to
clarify certain information mentioned in Articles 54 and 59(1) and other information
compatible with the summary of the product characteristics which is useful to the patient, to the
exclusion of any element of a promotional nature".
Purpose
The purpose of this guideline is to describe how the above mentioned provisions of the
Directive , apply in the case of a marketing authorisation to be granted by the Commission.
In particular, this guideline provide information on the items required by some Member States
under Article 57 of the Directive and also on the additional items included in the labelling
pursuant to Article 62 of the Directive in order to ensure that these are in conformity with the
legislative provisions and are correctly presented.
This shall assist applicants and marketing authorisation holders when drawing up the labelling
and package leaflet and preparing the mock-up and specimens of the sales presentation5.
Guidelines and other interpretative documents to which references may be included within this
document represent the views of their authors.
5
A mock-up is a copy of the flat artwork design in full colour, presented so that, following cutting and folding
where necessary, it provides a replica of both the outer and immediate packaging so that the three dimensional
presentation of the labelling text is clear. This mock-up is generally referred to as a paper copy and not necessarily
in the material of the sales presentation. A specimen is a sample of the actual printed out outer and immediate
packaging materials and package leaflet (i.e. the sales presentation).
5
Section A - Labelling
The Union authorisation of a medicinal product includes the labelling text which is the
same throughout the Union.
Article 9, paragraph 4 (d) of the Regulation provides that must be in annex of the
favourable CHMP opinion the draft text of the labelling proposed by the applicant and
presented in accordance with title V of the Directive.
Article 54 of the Directive lists the particulars that must appear on the outer packaging
of medicinal product or, where there is no outer packaging, on the immediate packaging.
Article 61(2) of the Directive provides that the labelling must comply with the
provisions of title V and the particulars listed in the summary of products characteristics.
For products authorised by the Union there is a single summary of product
characteristics agreed at EU level, which forms part of the Commission Decision
granting the marketing authorisation.
However, Article 63(3) of the Directive provides that "Where the medicinal product is
not intended to be delivered directly to the patient, or where there are severe problems
in respect of the availability of the medicinal product, the competent authorities may,
subject to measures they consider necessary to safeguard human health, grant an
exemption to the obligation that certain particulars should appear on the labelling and
in the package leaflet.[…]" Such requests for exemption regarding particulars must be
addressed to EMA.
Furthermore, Member States may require further information, see below point 3 and
some information may be added at the initiative of the applicant/marketing authorisation
holder, see below point 6.
Article 56 of the Directive provides that the particulars in the labelling shall be easily
legible, clearly comprehensible and indelible. For these aspects, reference is made to the
Guideline on the readability of the labelling and package leaflet of medicinal products
for human use6.
Reference is also made to Product information templates and reference documents
prepared by the Quality Review of Documents group and published by the EMA.
2. Language
Article 63(1), 1st and 2nd sub-paragraph of the Directive provides that
"The particulars for labelling listed in Articles 54, 59 and 62 shall appear in an
official language or official languages of the Member State where the medicinal
product is placed on the market, as specified, for the purposes of this Directive, by that
Member State.
6
Revision 1 of 12 January 2009 (ENTR/F/2/SF/jr (2009)D/869).
6
The first subparagraph shall not prevent these particulars from being indicated in
several languages, provided that the same particulars appear in all the languages
used".
This means that each Member State where the medicinal product is placed on the
market decide the official language in which the labelling must be presented. The
labelling must be presented at least in the language or languages of the Member
State(s) where the product is placed on the market. If more than one language is used,
then the content of all language versions must be identical and the overall readability
should not be adversely affected. . It is recommended to group different text elements
for each language, where appropriate.
However, in case of certain orphan medicinal products, Article 63(1), 3d sub-
paragraph of the Directive provides that "[…] the particulars listed in Article 54 may,
on reasoned request, appear in only one of the official languages of the Community".
Such request for exemption should be addressed to EMA.
In addition, article 63(3) of the Directive provides that "Where the medicinal product
is not intended to be delivered directly to the patient, or where there are severe
problems in respect of the availability of the medicinal product, the competent
authorities may, subject to measures they consider necessary to safeguard human
health, grant […] a full or partial exemption to the obligation that the labelling and
the package leaflet must be in an official language or official languages of the
Member State where the medicinal product is placed on the market, as specified, for
the purposes of this Directive, by that Member State." Such requests for exemption
regarding language should be addressed to concerned national competent authorities.
Article 60 of the Directive provides that Member States may not prohibit or impede the
placing on the market of a medicinal product which labelling and package leaflet comply
with requirements of Title V of the Directive.
However in accordance with article 57, Member States may require the use of certain
forms of labelling in order to ascertain:
− the price of the medicinal product,
− the reimbursement conditions of social security organizations,
− the legal status for supply to the patient, in accordance with Title VI of the
Directive,
− authenticity and identification in accordance with Article 54a(5).
Annex I of this document lists, by Member State, these national requirements.
7
The "blue box" is a boxed area included in the labelling, with a blue border, aimed at containing
information specific to each Member State.
7
for instance by printing a blank ‘blue box’ on this pack onto which a sticker with the
appropriate Member State information can be securely affixed. When in exceptional
circumstances, several 'blue boxes' are required for the different Member States; they
should ideally have the same dimensions and appear on the same side of the pack.
4. Legal status
In accordance with Article 9(4)(b) and 10(1) of the Regulation, the CHMP scientific
opinion and the Commission decision on the marketing authorisation must respectively
include "details of any conditions or restrictions which should be imposed on the supply
or use of the medicinal product concerned, including the conditions under which te
medicinal product may be made available to patients, in accordance with the criteria laid
down in Title VI of Directive 2001/83/EC".
Therefore the Commission decision may include one, or more, of the sub-categories
listed in Article 70 of the Directive as well as other conditions or restrictions on the
supply which are deemed necessary from a public health perspective.
8
In some Member States certain expressions, including symbols and pictograms have
become established for expressing certain items of information. As these particulars are
only known or relevant in some Member States, they should appear in the corresponding
‘blue box’ referred to above (see point 4). These are listed in the Annex of this
document.
Local representative
Article 1, point 18a of the Directive defines the representative of the marketing
authorisation holder as "the person, commonly known as local representative,
designated by the marketing authorisation holder to represent him in the Member
State concerned".
"Local Representative" should be taken to mean any natural or legal person
established in the Union charged, through a contract under private law with the
marketing authorisation holder, to represent him in a defined (geographical) area. This
agreement excludes any transfer of any responsibility imposed on the marketing
authorisation holder by Union law and by national law, regulation and administrative
action implementing such Union law.
Article 54(k) of the Directive provides that must appear on the labelling "the name and
address of the marketing authorisation holder and, where applicable, the name of the
representative appointed by the holder to represent him".
The designation of a local representative is not obligatory8.
The 'local representative' may be indicated in the ‘blue box' on the labelling by name,
telephone number and/or e-mail address and logo (optional). Postal address may be
included if space permits (should not interfere with the legibility of the text which must
mandatory appear on the outer packaging).
Local representatives should be able to address queries in the local official EEA
language(s) of the country for which they are designated.
For these aspects, reference is made to the Guideline on the readability of the label and
package leaflet of medicinal products for human use9.
8
ECJ T-179/00 of 3.07.2002.
9
Revision 1 of 12 January 2009 (ENTR/F/2/SF/jr (2009)D/869).
9
The labelling of the medicinal product forms part of the authorisation. To this end the
CHMP, in accordance with Article 8(3)(j) of the Directive, and Articles 6(1), 7(a) and
9(4)(d) of the Regulation, provides the Commission with its opinion whether the
labelling is in compliance with Title V of the Directive.
The proposed outer and immediate packaging and package leaflet will be reviewed for
compliance with the requirements provided in the Directive, during the scientific
assessment and linguistic review of the application. In addition, the EMA will perform
a general check of mock-ups and specimens from the viewpoint of readability in order
to contribute to the safe use of medicines (e.g. lay-out and design, font-sizes,
differentiation between strengths, etc).
In the case of a favourable opinion, the text of the labelling is attached to the CHMP
opinion, to be annexed to the Commission decision granting the marketing
authorisation.
Whilst most of the information referred to under point 3 (price, reimbursement
conditions, identification number) will not be available at the time of the adoption of
the Commission Decision, a clear indication on how this information will eventually
be presented shall be submitted with the application, as provided for in Article 8 (3) (j)
and in Article 61 (1) of the Directive through mock-ups of the outer packaging and of
the immediate packaging.
The requirements for mock-up and specimen submissions and details of the EMA
check are set-out in specific guidelines available on EMA website.
Article 61(3) of the Directive provides that: "All proposed changes to an aspect of the
labelling or the package leaflet covered by this Title and not connected with the
summary of product characteristics shall be submitted to the authorities competent for
authorizing marketing. If the competent authorities have not opposed a proposed
change within 90 days following the introduction of the request, the applicant may put
the change into effect". Therefore, if a marketing authorisation holder wishes either to
introduce any label text additional to that in the decision or to change any aspect of the
labelling, which is not linked to a modification of the SmPC, he must first notify this
change to the EMA, who shall inform him if the proposed change is not accepted
within 90 days following the introduction of the request. If necessary, the EMA
should inform the Commission, who should amend the decision granting the
marketing authorisation.
Where a change in the labelling is a consequence of a modification of the summary
product characteristics as part of a variation or renewal it will be dealt with under the
procedure laid down for that purpose.
Where a change to the labelling impacts only on the overall lay-out, design or
readability and not on the actual labelling text (in the Commission decision granting
the marketing authorisation), the need for an EMA review of the proposed changes by
means of the provision of mock-ups and specimens, should be discussed with the
EMA on a case-by-case basis, as outlined in specific guidelines available on EMA
website.
10
Section B - Package leaflet
The inclusion in the packaging of all medicinal products of a package leaflet is obligatory
unless all information required is directly conveyed on the labelling.
1. The text of the package leaflet
The Union authorisation of a medicinal product includes the text of the package leaflet,
which is the same throughout the Union.
Article 9, paragraph 4 (d) of the Regulation provides that must be in annex of the
favourable CHMP opinion the draft text of the package leaflet proposed by the applicant
and presented in accordance with title V of the Directive.
Articles 59(1) and 61(2) of the Directive provide that the package leaflet must comply
with the provisions of title V and the particulars listed in the summary of products
characteristics. For products authorised by the Union there is a single summary of
product characteristics agreed at EU level, which forms part of the Commission
Decision granting the marketing authorisation.
However Article 63(3) of the Directive provides that "Where the medicinal product is
not intended to be delivered directly to the patient, or where there are severe problems in
respect of the availability of the medicinal product, the competent authorities may,
subject to measures they consider necessary to safeguard human health, grant an
exemption to the obligation that certain particulars should appear on the labelling and in
the package leaflet […]"; Such requests for exemption regarding particulars must be
addressed to EMA.
Article 59 (3) of the Directive provides that "the package leaflet shall reflect the results
of consultations with target patient groups to ensure that it is legible, clear and easy to
use".
Article 63(2), 1st sub-paragraph of the Directive provides that "the package leaflet must
be written and designed to be clear and understandable, enabling the users to act
appropriately, when necessary with the help of health professionals. […]".
For these aspects, reference is made to the guideline on the readability of the labelling
and package leaflet of medicinal products for human use10.
Reference is also made to Product information templates and reference documents
prepared by the Quality Review of Documents group and published by the EMA .
2. Language
Article 63 (2), 1st and 2nd sub-paragraph of the Directive provides that:
"[…] The package leaflet must be clearly legible in an official language or official
languages of the Member State where the medicinal product is placed on the market, as
specified, for the purposes of this Directive, by that Member State
10
Revision 1 of 12 January 2009 (ENTR/F/2/SF/jr (2009)D/869).
11
The first subparagraph shall not prevent the package leaflet from being printed in
several languages, provided that the same information is given in all the languages
used".
This means that each Member States where the medicinal product is placed on the
market decide the official language in which the package leaflet must be presented. The
package leaflet must therefore be presented at least in the language or languages of the
Member State(s) where the product is placed on the market. If more than one language is
used, then the content of all languages versions must be identical and the overall
readability of the package leaflet should not be adversely affected.
However, article 63(3) of the Directive provides that "Where the medicinal product is
not intended to be delivered directly to the patient, or where there are severe problems
in respect of the availability of the medicinal product, the competent authorities may,
subject to measures they consider necessary to safeguard human health, grant […] full
or partial exemption to the obligation that the labelling and the package leaflet must be
in an official language or official languages of the Member State where the medicinal
product is placed on the market, as specified, for the purposes of this Directive, by that
Member State." Such requests for exemption regarding language should be addressed to
the concerned national competent authorities.
Local representative
For the concept see point 6 of section A on labelling.
Article 59(1) f) vi) of the Directive provides that the package leaflet should include
"the name and address of the marketing authorisation holder and, where applicable,
the name of his appointed representatives in the Member States".
Designation of a local representative is not obligatory11 . A local representative
may be designated for more than one Member State or EEA country and may also be the
marketing authorisation holder where no other local representative is indicated.
More than one local representative per Member State may be designated and listed in the
package leaflet, but this should not entail the risk of confusion for patients and, as such,
poses a risk to public health and that provided that the company can ensure the same
level and quality of service will be provided by all local representatives.
The 'local representative' may be indicated by name, telephone number and/or electronic
e-mail address and logo (optional). Postal address may be included if space permits
(should not interfere with the legibility of the text that must mandatory appear on the
packaging leaflet).
All telephone numbers should be accessible when dialled from abroad (e.g. when a toll-
free number is given which is not accessible from aboard, an alternative international
number may have to be added).
11
ECJ T-179/00 of 3.07.2002.
12
Local representatives should be able to address queries in the local official EEA
language(s) of the country for which he/she is designated.
The package leaflet of the medicinal product forms part of the authorisation. To this end
the CHMP, in accordance with Articles 7(a) and 9(4)(d) of the Regulation, provides the
Commission with its opinion whether the package leaflet is in compliance with Title V
of Directive 2001/83.
The proposed outer and immediate labelling and package leaflet will be reviewed for
compliance with the requirements provided in the Directive, during the scientific
assessment and linguistic review of the application. In addition, the EMA will perform
a general check of mock-ups and specimens from the viewpoint of readability in order
to contribute to the safe use of medicines (e.g. lay-out and design, font-sizes,
differentiation between strengths, etc).
In the case of a favourable opinion, the text of the package leaflet is attached to the
CHMP opinion, to be annexed to the Commission Decision granting the marketing
authorisation.
The requirements for mock-up and specimen submissions and details of the EMA
check are set-out in the specific guidelines available on EMA website.
13
Where a change in the package leaflet is a consequence of a modification of the
summary of product characteristics as part of a variation or renewal it will be dealt
with under the procedure laid down for that purpose.
Where a change to the package leaflet impacts only on the overall lay-out, design or
readability and not on the actual labelling text (in the Commission decision granting
the marketing authorisation), the need for an EMA review of the proposed changes by
means of the provision of mock-up and specimens should be discussed with the EMA
Medical Information Sector on a case-by-case basis, as outlined in specific guidelines
available on EMA website.
14
Section C - Presentation of the medicinal product
1. Pack sizes
When presenting a range of pack sizes for a medicinal product it is important that the
principles of rational use of medicinal products are taken into consideration.
As a EU marketing authorisation is valid throughout the EU, every pack size covered by
the authorisation may be available in any Member State. Therefore, the appropriate
range of pack sizes should be chosen in accordance with the duration(s) of treatment and
in accordance with the posology in the summary of product characteristics, and not in
accordance with local traditions or prescription habits.
For example, there could be :
- one pack size for a short course of treatment,
- one pack size for a monthly course of treatment
- and one pack size for each multiple of the above.
However, Article 82(3) of the Regulation provides that "Without prejudice to the unique,
Community nature of the content of the documents referred to in Article 9(4)(a), (b), (c)
and (d) and in Article 34(4)(a) to (e), this regulation shall not prohibit the use of two or
more commercial designs for a given medicinal product covered by a single marketing
authorisation".
Applicants/marketing authorisation holders wishing to make use of this provision can
contact the EMA to discuss its practical application and to review the proposed designs
in advance of marketing.
3. Pack composition
Multi packs: these packs are composed of several single packs of the same strength of a
medicinal product.
Treatment initiation pack: these packs are composed of different strengths of a medicinal
product. These presentations aim at giving to patients in once all strengths of a medicinal
product for the duration of their initiation, as the dosage may change during this period.
15
ANNEX
'Blue box'
Label information which may be required by Member States (under 57 of Directive 2001/83/EC as amended)
Label information which has become established in Member States (allowed under Article 62 of Directive
2001/83/EC as amended)
AUSTRIA
Price
The price is not required and not wanted on the label.
Reimbursement
The reimbursement conditions are not required and not wanted on the label.
Legal status
The following are the specific requirements for the expression of the legal status in the
boxed area:
• “rezept- und apothekenpflichtig” = available only on prescription and only in
pharmacies;
• “apothekenpflichtig” = available only in pharmacies;
• If the supply is not restricted to pharmacies, this has to be declared appropriately.
Radiopharmaceuticals :
• “Rezeptpflichtig. Abgabe nur an Inhaber einer Bewilligung für den Umgang mit
radioaktiven Stoffen gemäß Strahlenschutzgesetz“ = available only on prescription for
authorised personnel
16
“Achtung: dieses Arzneimittel kann die Reaktionsfähigkeit und
Verkehrstüchtigkeit beeinträchtigen.”
“Der Gruene Punkt” or other recycling symbols are accepted on the label, but not required.
Additional Requirements for the Package Leaflet
BELGIUM
Legal status
The legal status is required on the label:
in the case of medicinal products that are subject to medical prescription only
“Geneesmiddel op medisch voorschrift.” /“Op medisch voorschrift”.
« Médicament sur prescription médicale. » / « Sur prescription médicale »
“Verschreibungspflichtig”
in the case of medicinal products that are not subject to medical prescription
Vrije aflevering
Délivrance libre
Freie Abgabe
The major narcotic or psychotropic drugs, subject to special medical prescription, require
the following labelling: • a number/code assigned by the Minister of Public Health •
BULGARIA
Price
Reimbursement
18
There is no requirement for the reimbursement conditions to appear on the label.
Legal Status
− For medicinal products subject to medical prescription, the following expression should
appear:
По лекарско предписание
− For medicinal products subject to restricted medical prescription, the following expression
should appear:
По ограничено лекарско предписание
− For medicinal products reserved for treatments which can only be followed in a
hospital environment due to limited experience or in the interests of public health,
the following expression should appear:
За болнична употреба
− For pack size/sizes which is/are not intended to be delivered to a particular patient but used in
a hospital environment for several patients or several treatment courses of one patient, the
following expression should appear:
Болнична опаковка
− For medicinal products subject to special medical prescription, the following expression
should appear:
По специално лекарско предписание, and
1. a double red line positioned diagonally on the package labels – for medicinal
products containing narcotic substances,
2. a double blue line positioned diagonally on the package labels - for medicinal
products containing psychotropic substances.
The EAN code (bar code) is accepted but not required on the label.
Symbols or pictograms
Symbols for separate disposal and recycling in compliance with the Law on Waste Management
are required on the outer packaging label of a medicinal product.
The labelling may include symbols or pictograms as well as other information consistent with the
Summary of Product Characteristics and useful for the patient, excluding any element of
advertising.
Invented name
Invented name written in Bulgarian language to appear on the outer packaging.
CROATIA
Price
19
The price of medicinal product is not required on the label.
Reimbursement
Legal status
The following are the specific requirements for the expression of the legal status in the
boxed area:
• “Lijek se izdaje na recept.” = Medicinal product subject to medical prescription.
• “Lijek se izdaje bez recepta.” = Medicinal product not subject to medical prescription.
CYPRUS
Price
There is no requirement for the price to appear on the label. Nevertheless, according to
National Provisions, the price will be placed locally on the outer packaging (blue box) by
the retailer (pharmacist).
Reimbursement
Legal status
CZECH REPUBLIC
Price
Reimbursement
Legal Status
The legal status is required on the labelling the following text has to be used:
20
Section / Explanation Czech text required on the English translation
labelling
For medicinal products Výdej léčivého přípravku Medicinal product subject to
subject to medical vázán na lékařský předpis. medical prescription.
prescription
For medicinal products not Výdej léčivého přípravku Medicinal product not
subject to medical možný bez lékařského subject to medical
prescription předpisu. prescription.
21
DENMARK
Price
There is no requirement for the price to appear on the label.
Reimbursement
There is no requirement for the reimbursement conditions to appear on the label.
Legal status
There is no specific requirement in respect of the legal status.
ESTONIA
FINLAND
Price
There is no requirement for the price to appear on the label.
Reimbursement
There is no requirement for the reimbursement conditions to appear on the label.
Legal status
There is no requirement for the legal status to appear on the label.
22
Identification and authenticity
The Nordic number is required on the outer labelling of all medicinal products, except
radiopharmaceuticals, certain vitamin and mineral products, homeopathic and traditional
herbal medicinal products. It is written as “Vnr XX XX XX”.
A bar code is accepted on the label but not required.
• Products which may reduce the ability to drive or operate machines must have a
warning triangle. The tip of the triangle points upwards. It is a red triangle on a white
background. Its size is adapted to fit the label; its sides are usually 10 mm long and
the width of the frame is usually 2 mm:
FRANCE
Price
There is no requirement for the price to appear on the label.
Reimbursement
There is no requirement for the reimbursement to appear on the label.
Legal status
The legal status and other related specific warnings are required on the labelling for
prescription-only products. The following details must appear in the blue box:
1- for all prescription-only products
Active substances are classified in France in 2 categories based on whether or not the
supply to the patient may be repeated without a new prescription :
- List I (non renewable delivery)
- List II (renewable delivery)
23
There is no minimum size for the coloured border.
h) others restrictions or
information may apply on
a case by case basis
In case of medicinal products derived from blood, there are specific requirements:
Moreover, for these medicinal products derived from blood, three removable stickers
must be placed on the packaging; the entire name of the medicinal product (including
name, strength and pharmaceutical form), the name of the firm which operates the
placing of this product on the French market, the batch number and the corresponding
bar code must be printed on these stickers.
Active substances with this kind of effect but not yet listed by ministerial decree must have
a pictogram without mention of the risk level:
26
All pictograms and information on the risk level classification (1, 2 or 3) are available on
the ANSM website: www.ansm.sante.fr
2. Products with teratogenic or foetotoxic effects mentioned in the SPC must have a
pictogram and a corresponding warning message on the external packaging.
Three categories of pictograms apply, based on whether the medicinal product is contra-
indicated during pregnancy or not (case 1 or 2), or it contains valproate or related
substances (case 3); the associated warning message should specify the scope of the
recommendation (female adolescent or woman of childbearing potential without effective
method of contraception, pregnant woman, pregnant woman from the Xth month of
pregnancy):
HUNGARY
Price
Reimbursement
27
The reimbursement conditions are not required and not wanted on the label.
Legal status
The relevant sentence and legal status code is required to be expressed in the boxed area of
the label.
The EAN code (bar code) is accepted on the label, but not required.
GERMANY
28
Price
The marketing authorisation holder is not required to put the price on the label.
Reimbursement
The “Pharmazentralnummer” (PZN), has to be indicated on the labelling. The PZN can be
requested at:
Informationsstelle für Arzneispezialitäten – IFA GmbH
Postfach 15 02 61
D-60062 Frankfurt am Main
Phone: +4969/97 99 19-0
Fax: +4969/97 99 19-39
E-mail: ifa@ifaffm.de
Internet: http://www.ifaffm.de
The reimbursement conditions are required on the label:
• concerning the “N”-classification please see the attachements of the
“Packungsgrößenverordnung-PackungsV vom 22.06.2004 (BGBl. I S. 1318)” in the
current version
• •
• “Klinikpackung” for the hospital packsize
• “Unverkäufliches Muster” in the case of a sample pack size
The reimbursement conditions are not relevant for products sold directly to hospital units.
Co-Promotion
Name and address of the Co-Promotor
Legal status
The legal status is required on the label:
• “Verschreibungspflichtig” = to appear in the boxed area in the case of medicinal
products that are subject to medical prescription only
• “Apothekenpflichtig” = to appear in the boxed area in the case of medicinal
products that are not subject to medical prescription but are only available in pharmacies.
(No statement in the case of products which are neither prescription only nor pharmacy
only)
29
GREECE
Price
The price is required on the label.
Reimbursement
There is no requirement for the reimbursement conditions to appear on the label.
Legal status
If any of the sub-categories appear in the decision they are to be stated on the label. Other,
more specific requirements are outlined hereunder.
Specific national provisions (defined by EOF or by the Ministry of Health and Welfare in
compliance with SPC requirements and concerning either medicinal products subject to
special medical prescription or medicinal products subject to restricted prescription) must
appear on the label.
- For instance, medicinal products subject to special medical prescription (narcotics)
must have a letter/code assigned by the Ministry of Health and Welfare with special colour
(red or green) according to the assigned classification.
For medicinal products classified as narcotics according to Greek Law 1729/87 as
modified, the following text must appear on the label:
Products belonging to List B must mention in red letters “B, to be
dispensed with special prescription for narcotics”:
« Β,χορηγείται με ειδική συνταγή Ναρκωτικών »
Products belonging to the exceptions of list B must mention in
green letters “ΒΣ, to be dispensed with prescription of Law
1729/87”:
« ΒΣ, χορηγείται με συνταγή του Ν.1729/87»
Products belonging to list Γ must mention in red letters “Γ, to be
dispensed with special prescription for narcotics”:
«Γ, χορηγείται με ειδική συνταγή Ναρκωτικών»
d. Products belonging to the exceptions of list Γ must mention in
green letters “ΓΣ, to be dispensed with prescription of Law
1729/87”:
«ΓΣ, χορηγείται με συνταγή του Ν.1729/87»
e. Products belonging to list Δ must mention in green letters “Δ, to be
dispensed with prescription of Law 1729/87”:
«Δ, χορηγείται με συνταγή του Ν. 1729/87»
- Another instance relates to medicinal products restricted to hospital
use. These products must state “only for hospital use” on the label:
«μόνο για νοσοκομειακή χρήση »
IRELAND
Price
The price is not required on the label.
Reimbursement
There is no requirement for the reimbursement conditions to appear on the label.
Legal status
The non-prescription status of certain medicinal products, containing certain active
substances, must be stated. These active substances include: acyclovir, diclofenac
diethylammonium, famotidine, hydrocortisone, hydrocortisone acetate, ibuprofen,
ketoprofen, naproxen, nicotine, nicotine resinate, oxethazine and piroxicam, when
contained in medicinal products specifically authorised for sale without a prescription.
(Other medicinal products containing any of these active substances remain subject to
prescription control.)
The designation “POM” (for prescription-only medicines) is in common use and would be
in the boxed area.
ITALY
Price
The price is required on the label.
Reimbursement
Should a medicinal product be considered reimbursable by the National Health Service
(S.S.N.), the Company should insert within the blue box a peelable sticker containing the
following information, in compliance with the Decree of Ministry of Health 2 Agosto
2001:
• Bar code
• Name of the medicinal product (including strength, pharmaceutical form, units)
• National Identification Number
• Name of the Marketing Authorisation Holder
The following wording, printed in the area underneath the sticker, must appear once the
latter has
been removed: “Confezione dispensata dal SSN”
31
Legal status
The requirements in respect of the legal status are the following:
A) For medicinal products not subject to medical prescription one of the following is
required:
1 “Medicinale di automedicazione” (medicinal products for self-medication)
2 “Medicinale non soggetto a prescrizione medica” (medicinal product not subject to
medical prescription)
C) For medicinal products subject to non renewable medical prescription the following is
required:
1 “Da vendersi dietro presentazione di ricetta medica utilizzabile una sola volta”
G) For psychotropic and narcotic medicinal products falling within the scope of a specific
Italian law (D.P.R. 9 Ottobre n. 309 as amended) the following is required (in compliance
with the Decree of Ministry of Health 26 Marzo 1979):
1 “Soggetto alla disciplina del DPR 309/90 Tabella II <A><B><C><D><E>” For
psychotropic and narcotic medicinal products belonging to Table II, section A referred to
in D.P.R. 9 Ottobre n. 309 as amended, the statement must be marked with a red double
line as described below (in compliance with the Decree of Ministry of Health 26 Marzo
1979):
Pictograms
Doping pictogram: in compliance with the requirements of the Decree of Ministry of
Health 19 Maggio 2005 (implementing the Italian Law 14 Dicembre 2000 n 376 as
amended);
Smile pictogram: for non prescription medicinal products in compliance with the
requirements of the Decree of Ministry of Health 1 Febbraio 2002;
LATVIA
Price
Reimbursement
Legal status
33
The bar code is accepted on the label, but not required.
Any symbols and pictograms can be used (but it is not obligatory) on the label, if there are
no elements of advertising.
For example:
Products which may reduce the ability to drive or operate machines can have a warning
triangle. (A red triangle on a white background.)
Products containing inflammable material can have the international warming symbol
LITHUANIA
Price
Reimbursement
Legal status
LUXEMBOURG
There are no additional requirements.
MALTA
No further information is required in the blue box.
THE NETHERLANDS
Price
The price is not required on the labelling for medicinal products supplied without
prescription.
34
If a medicinal product is supplied on medicinal prescription, the price should be printed on
the pharmacy labelling.
Reimbursement
The reimbursement conditions are accepted but not required on the labelling.
Legal status
“If a medicinal product is only available on medical prescription, the legal status is
required to be expressed in the blue box area as “UR”, or “U.R.” or “uitsluitend recept”.
If a medicinal product is available without medical prescription, there are three routes of
supply for a medicinal product.
Section / Explanation Dutch text required on the English translation
labelling
If supply is restricted to "UA" “Only pharmacy”
pharmacy, this has to be "U.A."
expressed in the blue box "Uitsluitend apotheek"
areas a
If supply is restricted to "UAD" “Only pharmacy and
pharmacy and chemist's "U.A.D." chemist’s
(drugstore), this has to be "Uitsluitend apotheek en
expressed in the blue box drogist"
areas as
If supply is allowed in "AV" “General sale"
pharmacy, chemist's "A.V."
(drugstore) and general "Algemene verkoop"
sales, this has to be
expressed in the blue box
areas as
POLAND
Price
The price is not required and not wanted on the labelling.
Reimbursement
The reimbursement conditions are not required and not wanted on the labelling.
Legal Status
The legal status is required on the labelling.
The following are the specific requirements for the expression of the legal status in the
boxed area:
35
Section / Explanation Polish text required on English translation
the labelling*
Medicinal product not subject OTC – Lek wydawany OTC - Medicinal product not
to medical prescription bez recepty subject to medical
or prescription
OTC*
Medicinal product subject to Rp – Lek wydawany Rp - Medicinal product
medical prescription na receptę subject to medical
or prescription
Rp*
Medicinal product subject to Rpz – Lek wydawany Rpz - Medicinal product
restricted medical na receptę subject to medical
prescription or prescription
Rpz*
Medicinal product subject to Rpw – Lek wydawany Rpw - Medicinal product
special medical prescription na receptę subject to medical
(e.g. narcotic) or prescription
Rpw*
Medicinal product only for Lz – Lek stosowany Lz - Medicinal product only
hospital use w lecznictwie zamkniętym for hospital use
or
Lz*
* if justified description of legal category may be limited to abbreviation
PORTUGAL
Price and Reimbursement
The need of reference to the price and reimbursement on the labelling should be done
accordingly with the latest update of the specific national legislation.
In case of regulatory actions regarding Price, the sentence “PVP, se aplicável e de acordo
com os critérios e legislação em vigor” should be included within the boxed area.
However, this sentence will be replaced by the relevant information on the printed
materials.
36
Legal status
According to the national legislation, the legal status should be stated on the labelling.
The indication of the legal status is required, within the Blue Box, and it should be one of the
following:
* These expressions must only be included in the Blue box, if not previously presented on
the labelling.
- The expressions “Amostra gratuita” and “Proibida a venda ao público” or other similar
expressions should be added when applicable, as per the conditions expressed in the
national legislation.
ROMANIA
Price
37
There is no requirement for the price to appear on the label. Nevertheless, according to
national legislation, the price will be placed locally in the boxed area by the pharmacist.
Reimbursement
Legal status
The legal status is required to be expressed on the label for prescription-only products.
The following mentions must appear in the boxed area:
For medicinal products supplied in pharmacy based on medical prescription valid for 6
months (the supply prescribed may be repeated)
Medicament eliberat pe bază de prescripţie medicală – P6L
For medicinal products subject to restricted prescription (use in hospital only, use in certain
specialised areas, ambulatory use but the prescription must be done only by a specialist and
special follow up measures are necessary due to safety concerns).
Medicament eliberat pe bază de prescripţie medicală restrictivă – PR
38
SLOVAK REPUBLIC
Price
Reimbursement
Legal Status
The following are the specific requirements for the expression of the legal status in the boxed area:
Výdaj lieku je viazaný na lekársky predpis. = Medicinal products subject to medical
prescription.
Výdaj lieku nie je viazaný na lekársky predpis. = Medicinal product not subject to medical
prescription.
Výdaj lieku je viazaný na osobitné tlačivo so šikmým modrým pruhom. = Medicinal
product subject to special medical prescription with skew blue stripe.
Výdaj lieku je viazaný na lekársky predpis s obmedzením predpisovania.= Medicinal
product subject to restricted medical prescription.
The EAN code is required. Bar codes are accepted on the label, but are not required.
SLOVENIA
Price
Reimbursement
39
The reimbursement conditions are not recommended on the label.
Legal status
The following requirements on the legal status for supply to the patient are to be stated in
the boxed area:
For medicinal products, reserved for treatments, which can only be followed in a hospital
environment, the following information is required: "H - Zdravilo se izdaja le na recept,
uporablja pa se samo v bolnišnicah."
For medicinal products, reserved for treatments, which can only be followed in
institutions/health care centers with adequate facilities, the following information is
required": ZZ - Zdravilo se izdaja le na recept, uporablja pa se samo v javnih zdravstvenih
zavodih ter pri pravnih in fizičnih osebah, ki opravljajo zdravstveno dejavnost”.
For medicinal products, reserved for treatment of conditions which must be diagnosed in a
hospital environment, although administration and follow-up may be carried out elsewhere,
the following information is required: “H/Rp - Zdravilo se izdaja le na recept, uporablja pa
se samo v bolnišnicah. Izjemoma se lahko uporablja pri nadaljevanju zdravljenja na domu
ob odpustu iz bolnišnice in nadaljnjem zdravljenju”.
For medicinal products intended for outpatients, but which may produce very serious
adverse reactions requiring a prescription drawn up as required by a specialist and special
supervision through the treatment, the following information is required: Rp/Spec. –
“Zdravilo se izdaja le na recept, uporablja pa se po navodilu in pod posebnim nadzorom
zdravnika specialista ali od njega pooblaščenega zdravnika”.
For medicinal products not subject to medical prescription and supplied in pharmacies
only, the following information is required: "Zdravilo se izdaja brez recepta v lekarnah."
For medicinal products not subject to medical prescription and supplied either in
pharmacies or non-pharmacy outlets, the following information is required: "Zdravilo se
izdaja brez recepta v lekarnah in specializiranih prodajalnah."
If there is insufficient space on the label, only abbreviations can be used (i.e. H, ZZ, H/Rp
or Rp/Spec.)
Δ Medicinal products which may reduce the ability to drive or operate machines must
have a warning triangle (an empty triangle in the colour of the text)
! Limited quantity that may be dispensed at one time; the sign (!) in the colour of the
text
40
SPAIN
Price
The price can be included in the labelling in a voluntary basis (not mandatory).
Reimbursement
The reimbursement conditions should be included on a perforated detachable section that
will need to be reviewed for its acceptance by the following department of the Spanish
Ministry of Health:“Dirección General de Cartera Básica de Servicios del Sistema
Nacional de Salud y Farmacia”.
Legal status
These statements should be included in a visible place and using big enough font size to
ensure adequate readability. The corresponding acronyms (except for ‘EFG’) should be
included in the upper right corner of the package, between the national product number and
the symbols.
41
Section / Spanish text required on the English translation
Explanation labelling: acronyms
Medicinal products MEDICAMENTO SUJETO A Medicinal products subject
subject to medical PRECRIPCIÓN MEDICA to medical prescription
prescription (uppercase and bold format)
Medicinal products to “Uso hospitalario”: “H” Hospital use
be used in the hospital
Medicinal products “Diagnóstico hospitalario”: “DH” Hospital diagnosis
for diagnosis
performed in hospital
Legal status symbols: These symbols should be included in the upper right corner,
following the national product number and the legal status acronyms, as appropriate.
●
For narcotic medicinal products
∗
[to be included in the upper right corner, following the national product
number and the applicable legal status acronyms].
2. Driving: Those active substances affecting the ability to drive or use machines
(SmPC Section 4.7) and listed by the AEMPS on its website, should include the
following pictogram: [to be included together with a specific statement]
Material radioactivo
[Radioactive material]
UNITED KINGDOM
Price
There is no requirement for price to appear on the label.
Reimbursement
There is no requirement for reimbursement conditions to appear on the label.
Legal status
The legal status is required to be expressed in the boxed area as one of the following:
– if the medicinal product is available on prescription-only:
POM
– if the medicinal product is available without prescription, but through registered
pharmacies only:
P
EFTA STATES
ICELAND
Price
No requirement for price on the label.
Reimbursement
No requirement for reimbursement conditions on the label.
Legal status
No requirement for legal status on the label.
Identification and authenticity
Nordic commodity number required ( exception: radiopharmaceuticals and herbal
medicines). Written as Vnr XX XX XX. Bar code is accepted.
Information under Article 62 of Directive 2001/83/EEC: symbols or pictograms
Products which reduce the ability to drive or operate machines must have a warning
triangle. The tip of the triangle points upwards. It is a red triangle on a white background.
44
Its size is adapted to fit the label; its sides are usually 10 mm long and the width of the
frame is usually 2 mm:
NORWAY
Price
No requirement for price on the label.
Reimbursement
No requirement for reimbursement conditions on the label.
Legal status
No requirement for legal status on the label.
Identification and authenticity
Nordic commodity number required ( exception: radiopharmaceuticals and herbal
medicines). Written as “Vnr XX XX XX”. Bar code is accepted.
Information under Article 62 of Directive 2001/83/EEC: symbols or pictograms
Products which reduce the ability to drive or operate machines must have a warning
triangle. The tip of the triangle points upwards. It is a red triangle on a white background.
Its size is adapted to fit the label; its sides are usually 10 mm long and the width of the
frame is usually 2 mm:
45